We hypothesize that per-oral endoscopic myotomy has a higher long-term efficacy than pneumodilation in treatment of patients with recurrent symptoms after Heller myotomy
ID
Bron
Verkorte titel
Aandoening
achalasia
Per-oral endoscopic myotomy
Relapse
Pneumodilation
Secondary treatment
Laparoscopic Heller Myotomy
Ondersteuning
AMC Amsterdam, C2
Meibergdreef 9
1105 AZ Amsterdam
The Netherlands
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- Treatment success at one year, defined as:
An Eckardt score of 3 or less in the absence of additional retreatment after the allocated treatment (patients in the pneumodilation arm undergo 2 pneumodilations, with 30 and 35 mm and another one or two pneumodilations are allowing up to 40 mm in case of symptom recurrence within 1 year), patients in the POEM arm undergo POEM and no subsequent treatments)
Achtergrond van het onderzoek
Summary POEMA-2 trial
Idiopathic achalasia is a rare motility disorder of the oesophagus with an annual incidence rate of 1
per 100,000 persons. Achalasia i caused by progressive destruction and degeneration of the neurons
in the myenteric plexus. This leads to subsequent retention of food and saliva in the oesophagus,
resulting in the typical symptoms of achalasia such as dysphagia, chest pain, regurgitation of
undigested food and weight loss. On the long term, incomplete oesophageal emptying and reflux
result in an increased risk for development of squamous cell carcinoma of the oesophagus. The cause
of the neuronal degeneration found in achalasia is unknown.
Treatment procedures include: endoscopic pneumodilations (PD) and laparoscopic Heller myotomy.
Unfortunately, some patients experience recurrent or persistent symptoms after pneumodilations
and Heller myotomy. Patients with recurrent symptoms after undergoing a laparoscopic Heller
myotomy are usually treated with pneumodilation . However, the success rates of pneumodilation
after laparscopic Heller myotomy are only between 50-67% leaving a substantial proportion of these
patients with recurrent symptoms.
Recently, a new procedure has been introduced, the per-oral endoscopic myotomy. During per-oral
endoscopic myotomy the circular muscle layers of the lower oesophageal sphincter are cut similar
to the Heller myotomy, but the approach is through the wall of the esophagus with the endoscope
instead of laparoscopically.
This study compares the efficacy of POEM to the efficacy of pneumodilation for the treatment of
recurrent symptoms in patients with idiopathic achalasia that previously underwent Heller myotomy.
This study is a multicenter randomized clinical trial, including adult patient with persistent or
recurrent symptomatic idiopathic achalasia after Heller myotomy.
Doel van het onderzoek
We hypothesize that per-oral endoscopic myotomy has a higher long-term efficacy than pneumodilation in treatment of patients with recurrent symptoms after Heller myotomy
Onderzoeksopzet
3 months, 1, 2 and 5 years
Onderzoeksproduct en/of interventie
per-oral endoscopic myotomy (intervention)
Publiek
A.J. Bredenoord
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5661745
a.j.bredenoord@amc.nl
Wetenschappelijk
A.J. Bredenoord
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5661745
a.j.bredenoord@amc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Presence of achalasia as shown on oesophageal manometry at least once
2. Previous Heller myotomy
3. Eckardt score > 3
4. Significant stasis (stasis of >2 cm on barium oesophagogram after two minutes)
5. Age between 18-80 years
6. Signed written informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Previous pneumodilations after the Heller myotomy (pneumodilations before the Heller myotomy are allowed)
2. Previous (attempt at) POEM
3. Previous surgery of the stomach or oesophagus, except Heller myotomy
4. Known coagulopathy
5. Presence of liver cirrhosis and/or oesophageal varices
6. Presence of eosinophilic oesophagitis
7. Pregnancy at time of treatment
8. Presence of a stricture of the oesophagus
9. Presence of malignant or premalignant oesophageal lesions
10. Presence of one or more large esophageal diverticuli
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL4361 |
NTR-old | NTR4501 |
CCMO | NL48223.018.14 |
OMON | NL-OMON50756 |